P4983Safety of dobutamine stress contrast echocardiography; a single-center experience of 15 years

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
Y Dimitroglou ◽  
C Aggeli ◽  
T Tsiampalis ◽  
E Oikonomou ◽  
K Zisimos ◽  
...  

Abstract Introduction Dobutamine stress contrast echo (DSCE) is an accurate method for the diagnosis of coronary artery disease (CAD). Scarcity of serious adverse events has led to its establishment as a popular method for the diagnosis of CAD and to its increased use beyond CAD. However, data regarding the safety of single-line dobutamine and contrast infusion are limited. The aim of our study was to assess the safety of a DSCE protocol using a single line of intravenous access. Methods Over a 15-year period (2004–2018), 34,675 patients underwent DSCE in our department, which was performed using 10–20–30–40–50 μg/kg/h of dobutamine with dosage increase every three minutes, while atropine up to 1mg could also be administered. Two commercially available contrast agents were used at rest and at peak in all patients and a single intravenous line was used for infusion of dobutamine, atropine and contrast agents. Demographic data, risk factors and information concerning the most common cardiovascular or allergic adverse events were available for all patients. Finally, the adverse events of DSCE were compared with respective events reported by relevant studies in order to determine the safety of our method. Results Mean age of patient population was 63.9 (SD: 11.4 years), while 67.9% of patients (n=23,544) were males. There were 22,731 hypertensive patients (65.6%), 9,256 diabetics (26.7%), 21,683 patients (62.5%) had dyslipidemia, 11,760 (33.9%) were smokers and 10,437 (30.1%) had a positive family history of CAD. Adverse events were reported in 876 patients (2.5%). Allergic reaction was reported in 69 patients (0.2%). We recorded 643 patients (1.85%) with non-sustained VT or frequent premature ventricular ectopic beats and 154 patients (0.44%) with AF or SVT episodes leading to protocol termination. In 24 patients (0.07%) with sustained VT, antiarrhythmic drugs were given intravascularly, while in 10 patients (0.03%) with VT or VF, resuscitation was needed. No death was reported. Frequency of life threatening adverse events reported by relevant studies did not differ significantly when compared to the present results. Conclusion DSCE protocols involving single line infusion of dobutamine, atropine and ultrasound enhancing agents are safe, since adverse event rates are low and do not differ significantly to rates reported for unenhanced DSE by other relevant studies. Implementation of such protocols in clinical practice may increase patient comfort and cost-effectiveness and should therefore be encouraged.

2020 ◽  
Vol 10 (4) ◽  
Author(s):  
Thitima Sirimontakan ◽  
Ninuma Artprom ◽  
Nattachai Anantasit

Background: The volume of pediatric Procedural Sedation and Analgesia (PSA) outside the operating room has been increasing. This high clinical demand leads non-anesthesiologists, especially pediatric intensivists, pediatricians, and emergency physicians, to take a role in performing procedural sedation. Our department has established the PSA service by pediatric intensivists since 2015. Objectives: We aimed to assess the efficacy and safety of PSA outside the operating room conducted by pediatric intensivists and identify risk factors for severe adverse events. Methods: This was a retrospective descriptive study conducted from January 2015 to July 2019. Children aged less than 20 years who underwent procedural sedation were included. We collected demographic data, sedative and analgesic medications, American Society of Anesthesiologists (ASA) Physical Status Classification, indications for sedation, the success of procedural sedation, and any adverse events. Results: Altogether, 395 patients with 561 procedural sedation cases were included. The median age was 55 months (range: 15 to 119 months), and 58.5% (231/395) were male. The rate of successful procedures under PSA was 99.3%. Serious Adverse Events (SAE) occurred in 2.7%. Patients who received more than three sedative medications had higher SAE than patients who received fewer medications (adjusted for age, location of sedation, type of procedure, and ASA classification) (odds ratio: 8.043; 95% CI: 2.472 - 26.173, P = 0.001). Conclusions: Our data suggest that children who undergo procedural sedation outside the operating room conducted by pediatric intensivists are safe and effectively treated. Receiving more than three sedative medications is the independent risk factor associated with serious adverse events.


2014 ◽  
Vol 173 (3) ◽  
pp. 540-542 ◽  
Author(s):  
Constantina Aggeli ◽  
Ioannis Felekos ◽  
Dimitris Tousoulis ◽  
Polychronis Stergiou ◽  
Stella Plitaria ◽  
...  

2013 ◽  
Vol 154 (3) ◽  
pp. 83-92
Author(s):  
Mariann Harangi ◽  
Noémi Zsíros ◽  
Lilla Juhász ◽  
György Paragh

Statin therapy is considered to be safe and rarely associated with serious adverse events. However, a significant proportion of patients on statin therapy show some degree of intolerance which can lead to decreased adherence to statin therapy. The authors summarize the symptoms, signs and frequencies of the most common statin-induced adverse effects and their most important risk factors including some single nucleotide polymorphisms and gene mutations. Also, they review the available approaches to detect and manage the statin-intolerant patients. Orv. Hetil., 2013, 154, 83–92.


2020 ◽  
Vol 132 (6) ◽  
pp. 2000-2007 ◽  
Author(s):  
Soroush Niketeghad ◽  
Abirami Muralidharan ◽  
Uday Patel ◽  
Jessy D. Dorn ◽  
Laura Bonelli ◽  
...  

Stimulation of primary visual cortices has the potential to restore some degree of vision to blind individuals. Developing safe and reliable visual cortical prostheses requires assessment of the long-term stability, feasibility, and safety of generating stimulation-evoked perceptions.A NeuroPace responsive neurostimulation system was implanted in a blind individual with an 8-year history of bare light perception, and stimulation-evoked phosphenes were evaluated over 19 months (41 test sessions). Electrical stimulation was delivered via two four-contact subdural electrode strips implanted over the right medial occipital cortex. Current and charge thresholds for eliciting visual perception (phosphenes) were measured, as were the shape, size, location, and intensity of the phosphenes. Adverse events were also assessed.Stimulation of all contacts resulted in phosphene perception. Phosphenes appeared completely or partially in the left hemifield. Stimulation of the electrodes below the calcarine sulcus elicited phosphenes in the superior hemifield and vice versa. Changing the stimulation parameters of frequency, pulse width, and burst duration affected current thresholds for eliciting phosphenes, and increasing the amplitude or frequency of stimulation resulted in brighter perceptions. While stimulation thresholds decreased between an average of 5% and 12% after 19 months, spatial mapping of phosphenes remained consistent over time. Although no serious adverse events were observed, the subject experienced mild headaches and dizziness in three instances, symptoms that did not persist for more than a few hours and for which no clinical intervention was required.Using an off-the-shelf neurostimulator, the authors were able to reliably generate phosphenes in different areas of the visual field over 19 months with no serious adverse events, providing preliminary proof of feasibility and safety to proceed with visual epicortical prosthetic clinical trials. Moreover, they systematically explored the relationship between stimulation parameters and phosphene thresholds and discovered the direct relation of perception thresholds based on primary visual cortex (V1) neuronal population excitation thresholds.


2019 ◽  
Vol 14 (1) ◽  
pp. 31-36
Author(s):  
Raafat Abdel-Malek ◽  
Kyrillus S. Shohdy ◽  
Noha Abbas ◽  
Mohamed Ismail ◽  
Emad Hamada ◽  
...  

Background: Several single chemotherapeutic agents have been evaluated as the second-line treatment of advanced urothelial carcinoma. Despite encouraging efficacy outcomes, toxicity has often led to dose modifications or discontinuation. We aimed to assess the safety of vinflunine in a particular population of advanced transitional cell carcinoma of urothelium (TCCU), that were exposed to the previous toxicity of chemotherapy. Methods: This is an open-label, prospective, single-center pilot study to evaluate the response rate and safety profile of vinflunine in patients with advanced TCCU. It was planned to enroll 25 evaluable patients. Eligible patients are those with progressive disease after first-line platinum-based regimen for advanced or metastatic disease. Results: The study was prematurely closed due to two sudden deaths that were judged by the review board as treatment-related. Only ten patients were evaluated and received at least one cycle of vinflunine. All but one were male and seven underwent radical surgery. Eight had a distant metastasis (mainly lung and/or liver). Disease control rate was 40%, four patients had a partial response with median duration of response of 3.5 months. The median overall survival was 3.2 months (95% CI:1.67- 4.73). There were three serious adverse events namely two sudden deaths and one grade 4 thrombocytopenia. Nine grade 3/4 adverse events occurred. The most common all-grade adverse events were fatigue (50%), constipation (40%) and vomiting (40%). Moreover, grade 3 fatigue occurred in 30% of patients. Only one patient, who achieved PR for 5 months, was fit to receive further cytotoxic chemotherapy. Conclusion: The activity of vinflunine in advanced urothelial carcinoma came at the expense of its safety. The use of vinflunine has to be limited to the selected group of patients. However, this is a single institute experience in a limited number of patients.


2021 ◽  
pp. 174749302110069
Author(s):  
Heidi Janssen ◽  
Louise Ada ◽  
Sandy Middleton ◽  
Michael Pollack ◽  
Michael Nilsson ◽  
...  

Background: Environmental enrichment involves organisation of the environment and provision of equipment to facilitate engagement in physical, cognitive and social activity. In animals with stroke, it promotes brain plasticity and recovery. Aims: To assess the feasibility and safety of a patient-driven model of environmental enrichment incorporating access to communal and individual environmental enrichment. Methods: A non-randomised cluster trial with blinded measurement involving people with stroke (n=193) in 4 rehabilitation units was carried out. Feasibility was operationalised as activity 10 days after admission to rehabilitation and availability of environmental enrichment. Safety was measured as falls and serious adverse events. Benefit was measured as clinical outcomes at 3 months, by an assessor blinded to group. Results: The experimental group (n=91) spent 7% (95% CI -14 to 0) less time inactive, 9% (95% CI 0 to 19) more time physically, and 6% (95% CI 2 to 10) more time socially active than the control group (n=102). Communal environmental enrichment was available 100% of the time, but individual environmental enrichment was rarely within reach (24%) or sight (39%). There were no between-group differences in serious adverse events or falls at discharge or 3 months nor in clinical outcomes at 3 months. Conclusions: This patient-driven model of environmental enrichment was feasible and safe. However, the very modest increase in activity by people with stroke, and the lack of benefit in clinical outcomes 3 months after stroke do not provide justification for an efficacy trial. Clinical Trial Registration: ANZCTR 12613000796785 Words: 245


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